Every manufacturer knows how the atmosphere is in the plant prior to a regulatory inspection. Floors are clean; logbooks are in order; and somebody in QA hopes the inspector won’t ask to see the audit trail of the instrument that has been flashing the error message since March.
But here’s the catch: by the time of the inspection, most of the damage is already done. Everything that happens during the inspection period was determined months ago by the quality systems you’ve managed to build or neglect to build. Not a single brochure mentions this fact; however, that is precisely why it matters so much to choose the right GMP compliance company in India.
The value wasn’t in the inspection week; it was in the long and unattractive period leading to the inspection itself. Moreover, the quality systems built for sustainable results can provide you with such value.
You Don’t Build Compliance Quickly
There are plenty of manufacturers that approach compliance inspection the wrong way. They treat the compliance as a procedure you perform before the audit. Inspection notice arrives; the site goes into firefighting mode; and during the next two-three weeks the training documents are reconstructed, deviation backlog is reduced, and SOPs are finally rewritten to match the practices of the operators.
Inspectors are familiar with this process as they walk through enough plants to distinguish the system that has been developed throughout the years from the system that was established last month. They spot the ineffective closure of the CAPA. They ask when was the last time you qualified the supplier. The answer is “way too long ago”. They pull out of control result and go through its audit trail to discover the pattern that has never been analyzed.
One by one, the items aren’t critical on their own. All of them taken together allow the inspector to understand precisely what he needs to know, which is that your quality culture reacts to issues instead of predicting them. Repeat observation? It’s the worst of the bunch, proving that last time you’ve fixed symptoms instead of causes.
Sites that remain cool before the inspection aren’t the lucky ones; they’ve done the boring work early, and quite frequently with some outside assistance.
What the Quiet Work Involves
Good compliance work rarely starts with the auditor; it begins with the questions your internal team stopped asking, because you stopped noticing the issues that trouble you on daily basis. An experienced consultant walks the floor of the plant as an inspector does during the GMP audit, but unlike you, the inspector has a fresh perspective and notices the weaknesses.
And the list of weak spots discovered during such inspection looks familiar site after site. Deviation backlog growing from a few cases to forty without anybody addressing it. Vendor audits that are never repeated. Audit trail review that is present in the SOP, but nobody performs. Validation package missing that one bit of evidence that truly matters. Training records meeting the regulatory requirements, but not the training goals. These aren’t the checklist items, but the symptoms of a problem that has been developing over many years, and a good GMP compliance company in India brings value by explaining the list of items and closing them permanently, not only for the next visit.
Turning Findings into Systems That Hold
Identifying the weak spots is the easy part of the job; creating systems that ensure they will not return is the difficult one, and that’s when the experience pays off. Rather than suggesting you address all the weak spots at once, an experienced consultant will prioritize them based on actual risks. Data integrity issue with release testing instruments goes first. The change control process requiring revision is the priority in its own right. Formatting issues can wait. This prioritization is the difference between the team that addresses compliance gaps progressively and the one drowning in hundreds of open corrective actions. It allows you to create a plan that is feasible.
Underneath it all, there are the systems carrying all the weight: deviations, CAPA, change control, supplier qualification, complaints, risk management, release, training, document control. Let them communicate effectively and work properly, and compliance stops being something you show the visitors, and become something the site is run on.
This is the difference between appearing compliant and being compliant, and this is what allows the quality management system to function after the consultant is gone.
Identifying the weak spots is the easy part of the job; creating systems that ensure they will not return is the difficult one, and that’s when the experience pays off. Rather than suggesting you address all the weak spots at once, an experienced consultant will prioritize them based on actual risks. Data integrity issue with release testing instruments goes first. The change control process requiring revision is the priority in its own right. Formatting issues can wait. This prioritization is the difference between the team that addresses compliance gaps progressively and the one drowning in hundreds of open corrective actions. It allows you to create a plan that is feasible.
Underneath it all, there are the systems carrying all the weight: deviations, CAPA, change control, supplier qualification, complaints, risk management, release, training, document control. Let them communicate effectively and work properly, and compliance stops being something you show the visitors, and become something the site is run on.
This is the difference between appearing compliant and being compliant, and this is what allows the quality management system to function after the consultant is gone.
Why the Stakes Are Higher for India
The landscape has changed for Indian manufacturers. The revised Schedule M has increased the bar dramatically, and this new requirement is perceived as enforceable rules, not the paperwork exercise. At the same time, the manufacturers exporting to regulated markets have the USFDA, EMA, WHO-GMP, and PIC/S authorities to report to, and they became much stricter with data integrity, electronic records validation and ALCOA+ requirements. The questions an inspector asks nowadays about who is able to edit a record and who performs the audit trail review are much tougher than five years ago.
That is why you should look for a partner who will be able to read two maps at once. Knowledge of CDSCO and Schedule M alone is useless if the firm is ignorant of 21 CFR and EU-GMP, and vice versa. If you sell products in several markets, then the firm should be able to hold two maps in mind and move between them, because the inspection may be performed either by the state FDA officer, or an overseas investigator.
When to Hire Someone and What to Look For
The typical mistake is waiting till an inspection is scheduled. Much better is to do it earlier: if you commission a new facility, work through the revised Schedule M, enter a new export market, try to overcome the observations or improve your data integrity, or prepare for the customer audit.
Waiting until the inspection is scheduled gives you one thing that a last minute rush never can, which is the time to fix the compliance gaps properly and let people get used to new systems.
Once you start searching for the partner, consider the service list as table stakes. Everybody offers auditing, SOP review, and training. What actually distinguishes the firms is if they leave you with anything else besides the gap list. The right GMP compliance company in India provides you with systems that work and the team capable to operate them, not with the dependency on the consultants. Search for those who have undergone real inspections, not the ones who have read the guidelines. People who know how a manufacturing floor feels. People who stay through the implementation of the changes, not disappear after providing a gap report. And people who work with QA, QC, production, engineering and validation teams, rather than around them. The skill of knowing which observation the inspector will chase and which he will wave off, doesn’t come from the book. It comes from the experience of sitting in that room, on a number of sites, with different outcomes.
How Pharmazone Works
Since 2009, Pharmazone has been performing the compliance consulting services for pharmaceutical and life science |companies in India and abroad. With its main office located in Ahmedabad and its branch office in Shanghai, the company focuses on the results remaining after the inspections, not the nice look of the process.
The range of provided services includes gap assessment and pre-inspection mock audit, Schedule M compliance assistance, data integrity assessment, computerized system validation, QMS development, SOP and documentation support, CAPA and deviation management, GxP training, supplier qualification and global supplier audits and inspection readiness programs. Commit-Collaborate-Carry is only the shorthand for what the engagement actually is: we negotiate the desired result up front, work shoulder to shoulder with our clients’ team, rather than above them, and stay until their quality systems can function independently. Passing inspection should never depend on whether the consultants are still at the site or not.
To Sum It Up
Passing the inspection was never the goal. The goal is a quality system that produces compliant products, allows your people to answer an inspector without hesitations, and hold up the inspection without heroic efforts. The inspections without the questions are typically the best of all, and not because the questions are soft. It’s because the answers are built into the way the site operates. That is, ultimately, what the right GMP compliance company in India should leave behind.
Preparing for an inspection, dealing with revised Schedule M, improving your QMS, or entering a new regulated market?
Contact Pharmazone’s GMP team to discuss your compliance status and what should be done.
